BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 5346744 · Received January 6, 2016

    Report

    Report Number
    3007566237-2016-00049
    Event Type
    Injury
    Date Received
    January 6, 2016
    Report Date
    December 12, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    2015-12-12 LIT (HCP): GUL, F., GORDON, P., KROHN, P. CATHETER TIP INFLAMMATORY MASS FORMATION WITH BACLOFEN AND OPIOID INFUSION-CASE PRESENTATIONS (10781). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 87. SUMMARY: INTRATHECAL DRUG DELIVERY IS INCREASINGLY BEING RECOGNIZED AS AN OPTION FOR PATIENTS WITH CHRONIC SPASTICITY AND NONMALIGNANT PAIN THAT HAS BEEN REFRACTORY TO OTHER THERAPIES. A RARE COMPLICATION OF THIS THERAPY, FORMATION OF AN INFLAMMATORY MASS AT THE CATHETER TIP (REFERRED TO AS GRANULOMA), WAS ONCE THOUGHT TO BE LARGELY IN RELATION TO THERAPY WITH A HIGH-CONCENTRATION/HIGH-DOSE MEDICATION. IN OUR CENTER WE MANAGE APPROXIMATELY 500 SPASTICITY AND PAIN PUMP PATIENTS FOUR OF WHICH HAVE DEVELOPED GRANULOMA AT THE SITE OF THE CATHETER TIP. WE HAVE HIGHLIGHTED THESE CASES THAT DEVELOPED A CATHETER TIP GRANULOMA WITH DIFFERENCES IN DIAGNOSIS, MEDICATIONS, AND PUMP HISTORY. ATTEMPTING TO IDENTIFY PATIENTS AT RISK FOR DEVELOPING THIS RARE COMPLICATION OF INTRATHECAL DRUG DELIVERY IS CHALLENGING AS THERE DOES NOT APPEAR TO BE CLEAR PATTERNS WITH TYPE OF MEDICATION USED IN THERAPY LEADING UP TO THE DEVELOPMENT OF THE MASS. REGULAR NEUROLOGICAL CLINICAL EXAMS, GOOD COMMUNICATION WITH PATIENTS REGARDING CONDITION CHANGES AND IMAGING WHEN INDICATED BY CHANGES IN NEUROLOGIC STATUS OR NEW REFRACTORY PAIN AND SPASTICITY CAN BE RECOMMENDED IN THIS POPULATION. REPORTED EVENTS: CASE 1: (B)(6) YEAR OLD FEMALE WITH SPASTIC HEMIPARESIS FOLLOWING CVA WHO DEVELOPED A GRANULOMA APPROXIMATELY 5 YEARS AFTER INITIATING ITB THERAPY. PATIENT UNDERWENT TO EXISION OF MASS AND SHE SUFFERED WITH SPINAL CORD INJURY AND REMAINED PARAPLEGIC AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7848 INTRATHECAL CATHETER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_CATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Other| R